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IRCT20210217050393N4 IRCT 2023-08-05 Mashhad University of Medical Sciences Effect of an anti-inflammatory formula for Oral Nutrition Support (ONS) in critically ill patients admitted to the intensive care unit Design and development of an anti-inflammatory formula for Oral Nutrition Support (ONS) and its effects on inflammatory markers, antioxidants status and clinical outcomes in critically ill patients admitted to the intensive care unit: A double blined randomized control trial 2023-07-15 anticipated 74 Complete https://irct.ir/trial/70721 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be with blocks of 4, the random list will be created by https://www.sealedenvelope.com/. Patients are assigned to two control and intervention groups using sealed envelopes with block randomization method. In this way, in blocks of 4 which are divided into four states and each of these states is randomly selected from the sealed envelopes, 4 people in the control and intervention groups are allocated based on the selected state of the sealed envelope. It will be given. The same process continues until the allocation of all participants in the control and intervention groups, Blinding description: After the preparation of the sachet (containing the vitamins, minerals and nutrients mentioned) by the specialized pharmacy team and the professors of the pharmaceuticals department and then adding it to the standard Intramil formula to prepare the formula of the intervention group, both the control and intervention group formulas are transferred to the hospital and In the hospital kitchen, after preparing the gavage solution in bottles of the same shape, it is numbered and coded, and it is transferred to the ICU and given to the relevant nurse, and to the patients who were previously divided into two control and intervention groups. The approval will be divided according to the amount of calories required and the amount of volume requested by the patient's doctor. Considering that the researchers, nurses and patients do not know about the numbering and coding of the gavage solution of the patients, and due to the identical appearance, texture and organoleptic characteristics of the gavage solutions of the two groups, the blinding process is done with great care. 3 Condition 1: sepsis. Condition 2: Acute respiratory distress syndrome (ARDS). Condition 3: critically ill patients. Intervention 1: Intervention group: after determining the daily needs of the intervention group, 500 cc of the anti-inflammatory oral nutritional supplement (ONS) formula in 2 meals and in the form of a bolus, and the rest of the energy needed by the patient is also provided through hospital gavage. Intervention 2: Control group: After determining the daily needs of the control group, 500 cc of the standard formula (Standard Entrameal) in 2 meals and in the form of a bolus and the rest of the energy required by the patient is also provided through hospital gavage. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The data release schedule is not yet clear and no decision has been made in this regard.
public Sajedeh Jandari
School of Medicine, Mashhad University of Medical Sciences. Azadi Square, Campus of University, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2418 sjandaris@gmail.com Mashhad University of Medical Sciences scientific Reza Rezvani
Azadi Square, Campus of University, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2418 RezvaniR@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age 65-18 years Normal Gastrointestinal function Having indication for enteral nutrition 18 years no limit Both Impossibility of enteral feeding in the first 48 hours of admission History of underlying advanced heart disease Patients who are hospitalized in the intensive care unit for less than 96 hours. Patients expected to die within 12 hours of admission to the intensive care unit. Patients who do not have an indication for enteral nutrition on the first day, and based on the diagnosis of the intensive care unit, it is confirmed and predicted that they will not be able to receive enteral nutrition in the future. Patients who are under nutritional support by complete Parenteral Nutrition. Patients who have a history of underlying disease such as uncontrolled diabetes, congenital and immune disorders, advanced kidney and liver failure, and pancreatitis. Lack of consent of the patients or their legal guardian Treatment - Other Placebo Intervention group: after determining the daily needs of the intervention group, 500 cc of the anti-inflammatory oral nutritional supplement (ONS) formula in 2 meals and in the form of a bolus, and the rest of the energy needed by the patient is also provided through hospital gavage. Control group: After determining the daily needs of the control group, 500 cc of the standard formula (Standard Entrameal) in 2 meals and in the form of a bolus and the rest of the energy required by the patient is also provided through hospital gavage. (hs-crp) Inflammatory factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit. ESR inflammatory factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit. TAC antioxidant factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit. MDA antioxidant factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit. SOFA disease severity measure. Timepoint: At baseline, day 7 and day 14. Method of measurement: SOFA score questionnaire. Mashhad University of Medical Sciences Approved 2023-05-30 research ethic committees of School of Medicine -Mashhad University of Medical Sciences Azadi Square, Campus of University, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)